Hinged therapeutic mouthpiece

ABSTRACT

This invention relates to devices for insertion into the mouth for the application of heat or cold to oral tissue to provide a therapeutic effect. The device  10  includes an upper member  11  substantially conforming to a contour of an upper gum line, a lower member  12  substantially conforming to a contour of a lower gum line, a first hinge member  13,  and a second hinge member  14,  wherein at least one hinge member  13, 14  is configured to exert a compressive force to maintain the upper member  11  substantially in contact with an upper gum and the lower member  12  substantially in contact with a lower gum.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/378,079 filed Mar. 17, 2006, which is a contnuation of U.S.application Ser. No. 10/715,994 filed Nov. 18, 2003, now U.S. Pat. No.7,044,929, which is a continuation of U.S. application Ser. No.10/209,310 filed Jul. 31, 2002, now U.S. Pat. No. 6,660,029, whichclaims the benefit of U.S. Provisional Application No. 60/309,327 filedAug. 1, 2001, the disclosures of which are hereby expressly incorporatedby reference in their entirety and are hereby expressly made a portionof this application.

FIELD OF THE INVENTION

This invention relates to devices for insertion into the mouth for theapplication of heat or cold to oral tissue to provide a therapeuticeffect.

BACKGROUND OF THE INVENTION

Cryoanesthesia, or the localized application of cold as a means ofproducing regional anesthesia, for non-parenteral relief of pain is anaccepted method for treating oral tissue. The basic physiologic effectsof cooling tissue may include decreased local metabolism,vasoconstriction, reduced swelling, decreased hemorrhage, and analgesia.The magnitude and/or type of the effect generally depends upon theapplication method and duration of the treatment. Cryoanesthesia orcryotherapy may be preferred for a variety of indications, includingdecreasing swelling or bleeding after oral surgery, to treat burns, toreduce inflammation due to allergic reaction, or to reduce pain.Conventionally, cryoanesthesia or cryotherapy involves externalapplication of ice or cold packs to the jaw or face.

Likewise, heat therapy or thermal treatments may be useful for certainconditions of the oral tissue. For example, application of heat mayrelieve painful muscle spasms or cramping, or the pain oftemporomandibular joint disease or headache. As with cryotherapy, heattherapy conventionally involves application of a hot pack or heating padto the skin of the jaw or face. The conventional methods of applyingheat or cold to oral tissue suffer the drawback that the heat or coldmust be conducted through the skin and underlying tissue to the oraltissue to be treated.

SUMMARY OF THE INVENTION

There is a need for a device and method for effectively and efficientlyproviding anesthesia or pain relief to the oral tissue. Specifically, adevice and method that may be used to apply heat or cold directly to alocalized area of the oral tissue may be especially desirable.

One aspect of the present invention includes the realization that oralthermal therapy can be more effective and efficient if the device isplaced in direct contact with oral tissue that is the subject oftherapy. Indirect application of heat or cold to oral tissue is lessefficient because the thermal energy is conducted through facial skinand the underlying tissue, thereby attenuating the flow of thermalenergy into and out of the oral tissue to be treated. Thus, by directlyapplying heat or cold to a localized area of oral tissue, anesthetic andother effects can be achieved more effectively and efficiently.

The preferred embodiments of the present invention facilitate theapplication of cold to the gums, which may be especially helpful toreduce pain and swelling before, during, and after dental or otherprocedures, and for alleviating pain associated with trauma to the oralcavity. The application of cold may also provide relief from mouth soresand headaches, and may be helpful in pretreatment for certainprocedures. The device of preferred embodiments may offer a significantadvantage over ice cubes, cold drinks, and the like, because itlocalizes the cold to the gums or oral tissue without affecting theteeth. It is beneficial to avoid contact with the teeth since they areoften sensitive to cold. The invention also has the advantages of beingreusable and minimally invasive.

One preferred embodiment is a device that can be positioned between thegum line and the inner wall of the cheek. In one aspect of a preferredembodiment, two tube-like, flexible elements are curved in asemicircular shape or other shape similar to the curve of a patient'sgum line. These semicircular elements are preferably connected to eachother by two bendable hinge members. The bendable hinge members may beintegral with the semicircular elements, or may be removably attached tothe semicircular elements by an appropriate joint configuration.

When worn within the mouth, one semicircular element contacts the uppergum, one semicircular element contacts the lower gum, and the hingemembers are positioned toward the back of the mouth. The thickness ofthe semicircular elements is preferably selected such that they extendover the gum area, while minimizing contact with the teeth. The hingemembers allow the device to deform slightly when a gently squeezingpressure is applied. Compressing the device in this way facilitatespositioning the device in the mouth. The hinge members are also slightlycompressed during normal use, and the pressure exerted in opposition tothe compression force helps the device remain in position within themouth. The hinge members preferably operate in a manner that does notrisk trauma to the gum or cheek area.

In one preferred embodiment of the invention, the semicircular elementsare hollow and are filled with a non-toxic solution that, when cooled,still remains flexible. In an alternative embodiment, the semicircularelements are solid and composed of a material that is capable ofretaining cold or heat without the aid of an encapsulated substance. Inother embodiments, a spongy material capable of retaining a cooling orheating material is utilized. In each embodiment, the semicircularelements are preferably soft for comfort yet durable so as to avoidcompromising the device if it is accidentally bitten or used inconjunction with braces, dentures, or other oral or medical devices orprocedures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a provides a rear, top, and left side perspective view of adevice of a preferred embodiment.

FIG. 1 b provides a top plan view of the device of FIG. 1 a.

FIG. 1 c provides a rear elevational view of the device of FIG. 1 a.

FIG. 1 d provides a sectional view taken along line 1 c-1 c of FIG. 1 c.

FIG. 1 e provides an enlarged view of a portion of the device identifiedby a circle in FIG. 1 d.

FIG. 2 a provides a rear, top, and right side perspective view of adevice of a preferred embodiment.

FIG. 2 b provides an enlarged view of a portion of the device identifiedby a circle in FIG. 2 a.

FIG. 3 a provides a plan view of a device of a preferred embodiment.

FIG. 3 b provides a front elevational view of the device of FIG. 3 a.

FIG. 3 c provides a sectional view taken along line 3 a-3 a of FIG. 3 a.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description and examples illustrate a preferred embodimentof the present invention in detail. Those of skill in the art willrecognize that there are numerous variations and modifications of thisinvention that are encompassed by its scope. Accordingly, thedescription of a preferred embodiment should not be deemed to limit thescope of the present invention.

Devices for use in the oral cavity to provide soothing or pain reliefare described in the patent literature, for example, U.S. Pat. No.5,819,144 “Therapeutic mouthpiece”; U.S. Pat. No. 4,983,122 “Dentalcompress”; U.S. Pat. No. 5,323,787 “Custom fitted mouthpiece w/medicatedpad and container”; U.S. Pat. No. 3,885,403 “Hot and cold compress”;U.S. Pat. No. 5,782,868 “Gel filled teething device”; U.S. Pat. No.5,606,871 “Pacifier shaped teether with cold storage container”; U.S.Pat. No. D420,447 “Teething ring”; U.S. Pat. No. D411,303 “Vibratingteething ring”; U.S. Pat. No. 5,902,322 “Vibrating teething ring”; U.S.Pat. No. 5,766,223 “Child's teething device”; U.S. Pat. No. D391,363“Teething ring”; U.S. Pat. No. 5,666,693 “Toy handle for oral device”;U.S. Pat. No. 5,653,731 “Pacifier having a shield with chewing beads”;U.S. Pat. No. 5,649,964 “Vibrating teething ring device”; U.S. Pat. No.5,606,871 “Pacifier shaped teether with cold storage container”; U.S.Pat. No. 5,551,952 “Teething ring”; U.S. Pat. No. 5,520,016 “Ring andcatch and method”; and U.S. Pat. No. 5,515,870 “Thumb and finger suckingprevention device.” Teething rings and other cold compress devices arecommercially available, including Doctor's Choice Gum Soother marketedby Danara Intl., Ltd., of North Bergen, N.J.; Playskool Ice CreamTeether marketed by Safety 1^(st), Inc. of Canton Mass.; Cooling GumSoother marketed by Babies Best, Inc., of Vernon, Calif.; and Certi CoolInstant Cold Compress marketed by Certified Safety Manufacturing, Inc.of Kansas City, Mo. Such devices may have certain drawbacks that makethem unsuitable or not preferred for use in certain applications.

In contrast, the devices of the preferred embodiments are useful in avariety of applications, and are particularly effective in administeringcryoanesthesia to localized areas of the oral tissue.

Referring to the FIGS. 1 a, 1 b, and 1 c, a preferred embodiment of adental device 10 or mouthpiece as shown includes a lower element 11, andan upper element 12 curved to fit along an average gum line. Preferably,the upper and lower elements 11, 12 are rod or tube shaped. The lowerelement 11 is specially shaped to conform to the lower gum line and theupper element 12 is specially shaped to conform to the upper gum line.

Elements 11, 12 are also preferably capable of deforming sufficiently tocomfortably fit different gum lines. The dimensions of elements 11, 12are such that in an average application, the device maximizes contactwith the gums while minimizing contact with the teeth. In variousembodiments, the dimensions of the device may be adjusted as desired tofit certain jaw sizes, e.g., children of various ages, adult women,adult men, and the like. Alternatively, if the device is for use inveterinary applications, the dimensions of the elements may be selectedso as to provide a proper fit to the gum line of the animal beingtreated.

As depicted in FIG. 1 d, the cross-sectional view along line 1 a-1 a ofFIG. 1 c, the elements 11, 12 are hollow and have a relatively thinwall, as depicted in the enlarged view provided in FIG. 1 e. Preferably,the elements 11, 12 have a maximum outer diameter of about 3 mm or lessto about 20 mm or more, preferably about 4, 5, or 6 mm to about 15, 16,17, 18, or 19 mm, more preferably about 7, 8, or 9 to about 11, 12, 13,or 14 mm, and most preferably about 10 mm.

The preferred maximum outer diameter of elements 11, 12 may vary,depending upon the characteristics and configuration of the oral cavity.Preferably, the thickness of the wall of the elements 11, 12 is lessthan about 0.5 mm to greater than about 2 mm, preferably about 0.75 mmto about 1.25 to 1.5 mm, most preferably about 1 mm. The preferredthickness may vary, depending upon the material from which the tube isfabricated. Thinner walls may facilitate heat transfer and flexibilityof the device, while thicker walls may provide improved structuralintegrity, durability, and rigidity. While tubing having a circularcross section is generally preferred, tubing having an oval orelliptical cross section, or any other suitable shaped cross section,may also be preferred.

As depicted in FIGS. 1 a, 1 b, 1 c, 1 d, and 1 e the lower element 11 isconnected to the upper element 12 by bendable hinge members 13, 14. Thehinge members 13, 14 are configured to maintain a slight downward forceon element 11 against the lower gum and a slightly upward force onelement 12 against the upper gum when the device 10 is positioned in theoral cavity.

FIG. 2 a provides detail for the hinge member depicted in the device ofFIG. 2 b. In this embodiment, elements 11, 12 are fabricated from ovaltubing, while the hinge members 13, 14 are fabricated from tubing havinga circular cross section. Sections of tubing 15, 16 provide a transitionfrom the oval tubing of elements 11, 12 to round tubing of the hingemembers 13, 14.

The transitions 15, 16, elements 11, 12, and hinge members 13, 14 may befabricated in any suitable or convenient manner. For example, thedifferent cross section shapes may be imposed on a unitary piece oftubing to form the transition members 15, 16, elements 11, 12, and hingemembers 13, 14. Alternatively, two or more sections of tubing or shapedpieces may be affixed or joined together to form transition members 15,16, elements 11, 12, and hinge members 13, 14.

In a hinge member 13 of one embodiment, depicted in FIGS. 3 a-c,transition members 15, 16 are situated on either end of hinge member 13.The transition members 15, 16 are provided with connectors 17, 18 havingat least one annular projection 21, 22, 23. The connectors 17, 18 areconfigured to form a seal with elements 11, 12 upon insertion of theconnector 17 or 18 into a lumen at an end of element 11 or 12.Preferably, the maximum diameter of the annular projections 21, 22, 23is slightly larger than the inner diameter of the elements 11, 12, whichare constructed of a flexible material, thereby providing a secure fitafter insertion of the connectors 17, 18 into the ends of the elements11, 12.

In one embodiment, the device 10 is fabricated to have a specific hingeangle. In preferred embodiments, the hinge angle, when no compressiveforce is applied, may vary from about 5° or less to about 45° or more,preferably about 10° to about 40°, more preferably about 15° to about35°, and most preferably from about 20° to about 30°.

In preferred embodiments, the device is provided to the practitioner ina ready-to-use form. However, in certain embodiments, it may be desiredby the practitioner to adjust the device prior to use. For example, itmay be desirable to adjust the hinge angle so as to better conform thedevice to the shape of a particular patient's mouth, or to adjust theradius of the hinge member to increase or decrease the length of thearch for a comfortable fit. In such embodiments, the hinge members orother components of the device may be fabricated from a material that ispliable upon the application of heat, yet substantially resilient atroom temperature. The hinge or other member may then be heated, bentinto the desired shape or angle, then cooled to thereby retain its newshape.

In preferred embodiments, the material from which the hinge member isfabricated is preferably pliable yet have some degree of rigidity suchthat it can be bent into a new shape and substantially retain that newshape in the absence of deforming forces. The material is alsopreferably sufficiently resilient such that it can accommodate a rangeof deforming forces, for example, the natural movement of the mouth,without a substantial effect on the device's resting shape (i.e., itsshape in the absence of deforming forces). Materials that are pliable atroom temperature but which have memory, i.e., materials thatsubstantially return to their original shape after a deforming force isremoved, are generally preferred.

In preferred embodiments, the lower and upper elements 11, 12 areslightly compressed when the device is in position in the patient'smouth to maintain snug contact between the gum line and the inner wallof the cheek. In addition to gently holding elements 11, 12 in place,hinge members 13, 14 aid in moving the device into and out of the mouth.In a preferred embodiment, the hinge members 13, 14 and elements 11, 12are provided with an interlocking click mechanism that permits thelength of the arch to be adjusted to fit different jaw sizes. In such aconfiguration, the hinge member 11 or 12 and element 11 or 12 may bemoved apart or together then clicked in place to provide a comfortablefit.

The hinge member is preferably of a “E” shape, as depicted in theFigures. This configuration offers the benefit of improved compressionand comfortable fit when the device is in position, especially duringjaw movements, e.g., while speaking. However, in other embodiments,different hinge configurations may be preferred. For example, the hingemember may preferably be a simple “C” shape capable of exerting acompressive force. In other embodiments, the hinge member may include aleaf spring, torsional spring, or other spring, optionally incombination with a simple hinge not configured to exert a compressiveforce.

In preferred embodiments, the materials from which the device isconstructed are solid and have a satisfactory capacity for retainingheat or cold for an extended period of time while the device ispositioned in the mouth. The device may be cooled in a refrigerator orfreezer before it is positioned inside the mouth. Likewise, ifapplication of heat is desired, the material may be heated, e.g., inwarm water, a convection heating oven, a microwave oven, or the like,and then maintain its warm temperature for an extended period of timeafter it is positioned in the mouth. The material preferably is capableof maintaining its flexibility after it is chilled, if it used to cooloral tissue. Likewise, the material preferably is capable of maintainingsome degree of rigidity or form after it is heated, if it is to beutilized for warming oral tissue.

In an alternate embodiment, rather than being constructed of solidmaterial, elements 11, 12 are hollow and filled with a liquid or gelthat preferably is capable of maintaining its cold temperature (or warmtemperature) and flexibility (or rigidity) while in use. Thisencapsulated substance preferably is non-toxic, in case of accidentalleakage.

FIGS. 1 d and 1 e illustrate a cross section of a device having aconfiguration characterized by the internal fluid or gel chambers 19, 20of elements 11, 12. In a preferred embodiment, the encapsulatedsubstance is a two-phase system, for example, glycerol in water. In aparticularly preferred embodiment, a 10% glycerol solution in water isemployed. Also suitable for use is a 5 wt. % saline (NaCl) solution. Anysuitable liquid or gel may be used, however, including but not limitedto water, or water in combination with a non-toxic gelling substance.

For ease of fabrication, it is preferred to construct the two tube-likeelements 11, 12 from commercially available tubing of an acceptablediameter cut to an appropriate length. Such tubing generally has acircular cross-section. However, in certain embodiments it may bedesired to utilize tubing having a different cross-sectional shape, forexample, elliptical, semicircular, oval, square, triangular, orirregular shape. Likewise, it may be desired for the cross sectionalshape and/or area to vary along the length of the element. For example,it may be desirable to utilize a smaller cross-sectional area and/or athinner profile in areas adjacent to the lips, and a largercross-sectional area and/or a thicker profile in areas adjacent to thecheeks. Similarly, the thickness of the wall of the tube may be variedas desired, e.g. to provide a greater or lesser degree of flexibility orto facilitate transfer of heat or cold from the device to the oraltissue.

In certain embodiments, it may be desired to apply heat or cold to aonly one region of the mouth, for example, only the upper gums, thelower gums, the area adjacent to the back teeth, the area adjacent tothe front teeth, one side of the mouth, a particular tooth or teeth, oneor both hinges of the jaw, or the like. In such embodiments, it may bedesired to provide a tubular material comprising the tube-like elements11, 12 or hollow bendable hinge members 13, 14 with one or more septumsin the lumen of the member. The septum or septums delineate an area orareas to be filled with a liquid or gel that is capable of maintainingits cold temperature, with the remaining areas encapsulating air oranother material of lower heat capacity than the gel or liquid.Alternatively, elements 11, 12, 13, and/or 14 may comprise compositematerials. In such embodiments, a portion of a high heat capacity solidpolymer or other material may be secured to a portion of lower heatcapacity, e.g., a hollow air-filled tube or a polymeric material withlower heat capacity. In a particularly preferred embodiment, one or bothof elements 11, 12 may comprise a high heat capacity structure (e.g., asolid or spongy polymeric material or tube containing a cooling orheating gel or liquid), while the hinge members 13, 14 comprise hollowpolymeric structures.

In some embodiments, the hinge members 13, 14 do not directly contactthe gum line, and thus do not need to stay cold (or warm). By way ofspecific example, the embodiment depicted in FIG. 1 d where elements 11,12 are hollow, the internal fluid or gel chambers 19, 20 need not extendthrough the hinge members 13, 14 if cooling of the cooling of the hingemembers is not preferred. In other embodiments, the hinge members 13, 14may be formed integral with elements 11, 12 during the molding of theplastic material.

The devices of the preferred embodiments can be advantageously made fromany of a variety of medical grade or biocompatible materials, includingceramics, metals, polymers (such as homopolymers, copolymers,terpolymers, chemically or otherwise modified polymers, cross-linkedpolymers, coated polymers, resins, mixtures and combinations of polymersand the like), composites, and the like, which are well known to thoseof skill in the medical device manufacturing arts, includingpolytetrafluoroethylene (marketed under the tradename TEFLON™, availablefrom E.I. du Pont de Nemours and Company of Wilmington, Del.), variousdensities of polyethylene, nylon, polyethylethylketone (PEEK),polyethylene terephthalate (PET), polyether block amide copolymer(PEBAX), polymethylmethacrylate (PMMA), polytetrafluoroethylene (PTFE),polyurethane, polyvinylchloride (PVC), polydimethylsiloxane (PDMS),silicones, resin copolymers, and other materials known in the art. In aparticularly preferred embodiment, the polymeric material comprises astyrenic copolymer (marketed under the tradename KRATON™, available fromKraton Polymers of Houston, Tex.). Also preferred are siliconeelastomers in the 20 to 70 Shore A hardness range, available from GESilicones. Particularly preferred polymeric materials have a Shore Ahardness of about 10 or less to about 80 or more, preferably about 15,20, 25, or 30 to about 60, 65, 70, 75, 80, or 85, more preferably about30 or 35 to about 50 or 55, and most preferably about 40 to about 45.

Any of a variety of additional materials may also be used. Suitablemanufacturing methods and apparatus are also well known includinginjection molding and extrusion of the polymers and combination ofpolymers. Selection of suitable materials can be readily accomplished bythose of skill in the art, taking into account the desired physicalproperties of the finished device, as well as the desired manufacturingprocess and other product design considerations such as one time use.

Desired temperatures for the therapeutic application of heat or coldgenerally range from just above body-temperature (+37° C.) forheat-therapy to just above freezing (+0° C.) for cold-therapy. When heatis applied to the oral tissue, the temperature is preferably from about38° C. to about 49° C., more preferably from about 39, 40, or 41° C. toabout 46, 47, or 48° C., and most preferably from about 42 or 43° C. toabout 44 or 45° C. When cold is applied to the oral tissue, thetemperature is preferably from about 4° C. to about 15° C., morepreferably from about 5, 6, 7, or 8° C. to about 11, 12, 13, or 14° C.,and most preferably from about 9° C. to about 10° C. While these rangesare typically preferred for the application of cold or heat,respectively, in certain embodiments temperatures outside of theseranges may be preferred.

Heat may be generated within the device by an exothermic reaction orphase change, or may be transferred from a pre-heated mouthpiece toadjacent oral tissue. Likewise, cold may be generated by an endothermicreaction or phase change, or may be transferred to adjacent oral tissuefrom a pre-cooled mouthpiece.

In certain embodiments, it may be preferred that heating or cooling beprovided without the need for increasing or reducing the temperature ofthe mouthpiece by external means prior to insertion into the mouth. Insuch embodiments, the mouthpiece is maintained at ambient temperaturebut yields heat or cold when desired after initiation of a chemicalreaction, e.g., by mixing two chemical components maintained in separatecompartments in the mouthpiece, e.g., by piercing or otherwise rupturinga septum between the compartments. In other embodiments, it may bepreferred to apply heat or cold after the mouthpiece is removed from acooling or heating device. In such embodiments, a high heat capacitysubstance or a phase change material is preferably used. An example of acommon phase change material is ice, however other materials, such asencapsulated gels as are known in the art may also be used. In otherembodiments, it may be preferred to generate heat within the device bynon-chemical means, e.g., a resistive heating unit (either batteryoperated or provided with an external power source) incorporated intothe device.

It may be desired to reuse the device after appropriate disinfectingprocedures. In such embodiments, the device may be capable of reuseafter a regeneration process, such as reheating, recooling, or the like.Alternatively, if the device is adapted to be discarded after a singleuse, then an irreversible system may be employed, i.e., an endothermicor exothermic chemical reaction between two mixed components.

In a preferred embodiment wherein pre-cooling of the device by externalmeans is not desired, cooling is applied via a sodium-acetate-hydratephase change system contained within the device. The system comprises asodium acetate aqueous solution in metastable equilibrium at ambienttemperature and pressure, which undergoes a phase change upon additionof seed crystals or a pressure pulse. Pure sodium acetate is awater-soluble food-grade salt which forms a hydrate compound with waterin an endothermic reaction. The reaction may be reversed by heating.

Heating may be applied by using a heating system comprising water andanhydrous calcium chloride salt. When mixed, an exothermic reactionoccurs. Heat may also be generated by an oxidative exothermic process,e.g., oxidation of iron powder to iron oxide in the presence of awater-charcoal-salt-cellulose gel. In preferred embodiments wherein heatis to be applied, a paraffinic material such as hexadecane is used. Suchmaterials provide a more comfortable temperature level than most othersystems, and are generally non-toxic.

In certain embodiments, it may be preferred to incorporate a rubber-likepolymeric material into the device. The term “rubber-like,” as usedherein, is a broad term and is used in its ordinary sense, including,without limitation, a polymeric material exhibiting memory. A polymericmaterial exhibiting memory returns to its original shape when adeforming force is removed. Examples of rubber-like materials include,but are not limited to, chloroprene rubber, neoprene, styrene butadienerubber, acrylonitrile butadiene rubber, ethylene propylene dienemethylene (EPDM), and plastics such as polyvinylchloride andpolyethylene that are compounded and cured to impart rubber-likeproperties.

Such rubber-like materials may be solid or spongy. Spongy materialspossess a cellular structure. Spongy materials may generally be dividedinto two classes: open cell and closed cell. Open-cell sponges possessan interconnected cell structure that permits the absorption andcirculation of gases and liquids. The open-cell structure permits thespongy material to absorb and retain a heating or cooling material.Closed cell sponges incorporate a plurality of encapsulated pocketscontaining air or another gaseous material. Because the pores are notinterconnected, absorption of gases and liquids by the material isminimal.

In various embodiments, spongy materials of varying density may be used.For example, if it is desired that the device incorporate an open cellsponge, wherein the sponge absorbs a cooling or heating material, e.g.,cool or warm water, prior to insertion into the oral cavity, it may bepreferred to utilize a sponge with a low density. Alternatively, if thedevice contains a closed cell sponge, and the polymeric material of thesponge is pre-cooled or pre-heated prior to insertion into the oralcavity, a high density sponge may be preferred because of the greaterheat capacity of the polymeric material compared to the encapsulatedgas.

In another embodiment, the device is configured to permit circulation ofa cooling or heating medium at a desired temperature through the device.In such an embodiment, the device preferably incorporates an outer wallenclosing a lumen, wherein the lumen is interrupted at a single point onthe cross section of the lumen by a septum, with an ingress and anegress into the luminal space provided on either side of the septum. Thecooling or heating medium is supplied to the device via the ingress froma heating or cooling source and removed via the egress. If a high degreeof temperature control is desired, the heating or cooling source mayincorporate a reservoir containing the cooling or heating medium, ameans for heating or cooling the medium, e.g., a resistive heating coilor a cooling jacket, a thermostat, a pump, a supply line connecting thereservoir to the ingress, and a discharge line from the egress back tothe reservoir. Alternatively, if a high degree of temperature control isnot desired, the ingress may be connected to a supply of warm or coldtap water, and the egress connected to a drain.

In yet another embodiment, the device is configured to permit deliveryof a medicament or other desired substance to the tissue adjacent to thedevice. In such an embodiment, the device preferably incorporates apermeable outer wall enclosing a lumen, wherein the lumen is filled witha medicament or medicament-containing substance. Saliva present in themouth results in a fluid communication between the lumen and thesurrounding oral tissue through passages in the outer wall. This fluidcommunication permits the delivery of medicament to the surroundingtissue in a controlled fashion.

The rate at which the medicament is delivered may be regulated byadjusting the porosity of the outer wall of the lumen, with a greaterdegree of porosity correlating with a faster rate of delivery of themedicament. Depending upon the embodiment, the pores in the outer wallmay be large or small, or numerous or few. The desired degree and natureof the porosity may vary depending upon the medicament to be delivered,the material of the outer wall, the delivery rate of the medicament, theconcentration or amount of diluent in the lumen, and the like.Alternatively, the rate at which the medicament is delivered may beadjusted by providing the medicament in a matrix, which inhibitssolubilization, e.g., in a porous sponge, a slow-dissolving solidmatrix. The use of a matrix, diluent, or slow release system for themedicament may be preferred in certain embodiments, especially when aliquid medicament is utilized. Alternatively, the device may include asolid permeable substance with no lumen, wherein the medicament isincorporated into pores or passages of the permeable substance, or themedicament is imbedded into the material of a permeable wall.

In certain embodiments, it may be desirable to deliver both a medicamentand heat or cooling to the adjacent oral tissue. In such embodiments,the medicament may be imbedded into the wall material and a cooling orheating medium contained in the lumen. Alternatively, the device mayinclude a lumen divided along its length by a septum, with cooling orheating medium contained on one side of the septum, and the medicamenton the other side, with the outer wall adjacent to themedicament-containing portion of the lumen provided with passages orpores permitting fluid communication with surrounding oral tissue.

Various combinations of materials or composite materials, e.g., layeredmaterials or laminates, may be utilized, depending upon the desiredeffect.

It is generally preferred to apply cold to oral tissue using a device ofa preferred embodiment for a period of about 1 minute or less to about20 minutes or longer, preferably about 2, 3, or 4 minutes to about 10 or15 minutes, most preferably about 5 or 6 minutes to about 7, 8, or 9minutes. If desired, one or more additional cold treatments may then beapplied. It is generally preferred to provide an interval of severalminutes to half an hour between treatments, however in certainembodiments no interval or a longer interval may be desirable.

The devices of the various preferred embodiments are suitable for avariety of preoperative and postoperative uses. For example,preoperative uses may include, but are not limited to, the treatment ofpreexisting pain, swelling, infection, or trauma in the oral cavity.Postoperative uses include treatment of general discomfort followingperiodontal procedures, orthodontic procedures, endodontic procedures,oral and maxillofacial surgery, and general dentistry.

The devices of preferred embodiments can be useful in the treatment ofmaxillofacial and orofacial pain; in regional anesthesia applications;in applications involving nerve blocks without collateral numbness; inapplications where the patient is endentulous, allergic to epinephrineor other analgesics, or has high blood pressure or heart problems; andin applications where there is failed local anesthesia, pain fromimplantables, leucocytosis with chronic pain, masticatory musclehyperfunction, neuropathic pain, peripheral nerve injury, facialneuralgia, temporal mandibular disease, jaw joint pain, painful oralsores, oral mucositis pain, ondotostomatological pain, masticatorymuscle pain, root canals, severe toothache, extraction, deep scaling,root planing, and orthognathia and micrognathia with surgicalreconstruction. While the devices are particularly preferred for thenon-parenteral relief of pain by cryoanesthesia, the devices are alsosuitable for use in conjunction with conventional anesthetics,including, but not limited to, topical anesthetics, injectedanesthetics, and any other suitable means of inducing anesthesia. Issuesconnected with the use of anesthesia in the oral cavity are discussed inthe following references: Frank U. et al., “Vascular and cellularresponses of teeth after localized controlled cooling,” Cryobiology,1972 December, 9(6):526-33; Hutchings M L, “Nerve Damage and nerveblocks,” J. Am. Dent. Assoc., 1996 January; 127(1):25, Ellis S,“Sedation in general practice,” Br. Dent. J., 1996 Feb. 10, 180(3):88;Nist R A, et al., “An evaluation of the incisive nerve block andcombination inferior alveolar and incisive nerve blocks in mandibularanesthesia,” J. Endod., 1992 September, 18(9):455-9; Meier E,“Anesthesia problems in dentistry,” Schweiz Monatsschr. Zabrimed., 1993,103(2):205-7, 232-4; Jofre J, et al., “Design and preliminary evaluationof an extraoral Gow-Gates guiding device,” Oral Surg. Oral Med. OralPathol. Oral Radiol. Endod., 1998 June, 85(6):661-4; Martof A B,“Anesthesia of the teeth, supporting structures, and oral mucousmembrane,” Otolaryngol. Clin. North Am., 1981 August, 14(3):653-68;Weathers A, “Taking the mystery out of endodontics, Part 6. Painlessanesthesia for the “hot” tooth,” Dent. Today, 1999 December,18(12):90-3; Meechan J G, “How to overcome failed local anaesthesia,”Br. Dent. J., 1999 Jan. 9, 186(1):15-20; Lepere A J, “Maxillary nerveblock via the greater palatine canal: new look at an old technique,”Anesth. Pain Control Dent., 1993 Fall, 2(4):195-7; Noisser H O, et al.,“Management of chronic pain conditions—anesthesiologic aspects,”Chirurg., 1983 December, 54(12):785-8; Henthorn R W, et al., “A reliablemethod of testing regional block,” Reg. Anesth., 1993 March-April,18(2):139; Davies M W, et al., “Anaesthetic techniques for chair dentalanaesthesia,” Anaesthesia, 1995 October, 59(10):922-3; Quinn J H,“Inferior alveolar nerve block using the internal oblique ridge,” J. Am.Dent. Assoc., 1998 August, 129(8):1147-8; Gomolka K A, “The AMSA block:local anesthesia without collateral numbness,” CDS Rev., 2000 October,93(7):34; Franklin L K, “Electronic dental anesthesia: an injection-freealternative—a review,” Pract. Periodontics Aesthet. Dent., 1997January-February, 9(1):103-4, 106; Dhanji A R, “Overcoming failed localanaesthesia,” Br. Dent. J., 1999 Apr. 10, 186(7):316-7; Thomas J A,“Anesthetizing the dental pulp,” Endod. Rep. 1992, 7(2):6-8; Young E R,et al., “Successful mandibular anesthesia following numerousunsuccessful attempts: a case report,” J. Can. Dent. Assoc., 1993October, 59(10):845-50; Hannington-Kiff J G, “Cryoanalgesia forpostoperative pain,” Lancet, 1980 Apr. 12, 1(8172):829; Carpentier P,Rev. Odontostomatol. (Paris), 1985 November-December, 14(6):453-8,(French); DeWitt K, “What . . . another injection technique,” J. Wis.Dent. Assoc., 1984 January, 60(1):22-3; Hawkins P L, “The seconddivisions block: an easy cure for the “difficult to numb” patient,” GMDABull., 1987 March, 54(3):91-2; Gaillard M M, et al., “New techniques ofloco-regional anesthesia. What are they worth?” Inf Dent., 1988 Nov. 10,70(39):3901-6; Hogarth D L, “Maxillary nerve block anaesthesia,” Aust.Dent. J., 1991 August, 36(4):326; Durick R J, “The third and seconddivisions of the trigeminal nerve: dental considerations,” J. Tenn.Dent. Assoc., 1995 April, 75(2):18-22.

The preferred embodiments have been described in connection withspecific embodiments thereof. It will be understood that it is capableof further modification, and this application is intended to cover anyvariations, uses, or adaptations of the invention following, in general,the principles of the invention and including such departures from thepresent disclosure as come within known or customary practices in theart to which the invention pertains and as may be applied to theessential features hereinbefore set forth, and as fall within the scopeof the invention and any equivalents thereof Each reference citedherein, including but not limited to patents and technical literature,is hereby incorporated by reference in its entirety.

1. A device for applying heat or cold to a patient's oral tissue bycirculation of a heating or cooling medium through the device, thedevice comprising an upper member substantially conforming to a contourof an upper gum line, a lower member substantially conforming to acontour of a lower gum line, a first hinge member configured to providea compressive force, a second hinge member configured to provide acompressive force, and an outer wall enclosing a lumen, wherein thefirst hinge member joins a first end of the upper member to a first endof the lower member, wherein the second hinge member joins a second endof the upper member to a second end of the lower member, wherein thelumen is interrupted at a single point on a cross section of the lumenby a septum, and wherein an ingress and an egress configured forintroducing a heating or cooling medium into the lumen are provided oneither side of the septum, and wherein, when the apparatus is insertedinto a patient's mouth, the compressive force maintains the upper membersubstantially in contact with an upper gum and the lower membersubstantially in contact with a lower gum over a range of relativemotion of the upper gum and lower gum.
 2. The device of claim 1, whereinthe ingress is configured for connection to a supply of warm or cold tapwater, and wherein the egress is configured for connection to a drain.3. The device of claim 1, wherein each of said first hinge and saidsecond hinge has an “E” shape.
 4. The device of claim 1, furthercomprising a heating or cooling source comprising a reservoir configuredto contain a heating or cooling medium.
 5. The device of claim 4,further comprising a cooling jacket.
 6. The device of claim 4, furthercomprising a resistive heating coil.
 7. The device of claim 4, furthercomprising a thermostat.
 8. The device of claim 4, further comprising apump.
 9. The device of claim 4, further comprising a supply lineconnecting the reservoir to the ingress, and a discharge line from theegress back to the reservoir.
 10. A device for applying heat or cold toa patient's oral tissue by circulation of a medium through the device,the device comprising an upper member substantially conforming to acontour of an upper gum line hinged to a lower member substantiallyconforming to a contour of a lower gum line so that rotation of saidupper member towards said lower member about said hinge provides acompression force between said upper and lower member, and an outer wallenclosing a lumen, wherein the lumen is interrupted at a single point ona cross section of the lumen by a septum, and wherein an ingress and anegress configured configured for introducing a medium into the lumen areprovided on either side of the septum.
 11. The device of claim 10,wherein the ingress is configured for connection to a supply of warm orcold tap water, and wherein the egress is configured for connection to adrain.
 12. The device of claim 10, wherein said hinge has an “E” shape.13. The device of claim 10, wherein the hinge has a “C” shape.
 14. Thedevice of claim 10, further comprising a heating or cooling sourcecomprising a reservoir configured to contain a heating or coolingmedium.
 15. The device of claim 14, further comprising a cooling jacket.16. The device of claim 14, further comprising a resistive heating coil.17. The device of claim 14, further comprising a thermostat.
 18. Thedevice of claim 14, further comprising a pump.
 19. The device of claim14, further comprising a supply line connecting the reservoir to theingress, and a discharge line from the egress back to the reservoir.